Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
- Conditions
- Postsurgical Pain
- Interventions
- Drug: Multiprofen-CC™ plus standard treatmentOther: Placebo plus standard treatment
- Registration Number
- NCT06202989
- Lead Sponsor
- KAZM Pharmaceuticals Inc.
- Brief Summary
Total knee arthroplasty is a surgical treatment which involves replacing the damaged articular cartilage of the knee joint with an artificial prosthetic in end-stage knee osteoarthritis. Although total knee arthroplasties are mostly successful, approximately 1 in 5 patients are unsatisfied with their outcomes with 16-33% of patients of patients experiencing lasting pain following total knee arthroplasty.
Multiprofen-CC™ is a compounded topical analgesic currently available to healthcare professionals for prescription in patients experiencing localized musculoskeletal pain. To date there has been no evidence-based guidance generated to evaluate the efficacy of Multiprofen-CC™ in osteoarthritis patients. This study will test, in patients with end-stage knee osteoarthritis undergoing total knee arthroplasty, if the use of topical Multiprofen-CC™ in addition to standard of care pain management is more effective in controlling knee pain and reducing opioid use compared to placebo plus standard care alone.
- Detailed Description
Total knee replacement, also known as total knee arthroplasty (TKA), is a surgical procedure aimed at alleviating pain and improving joint function in individuals with severe knee joint damage, often caused by conditions like osteoarthritis (OA) While TKAs generally yield positive results, a significant amount of patients express dissatisfaction with their outcomes, with some continuing to experience persistent pain after surgery. Opioids are very commonly prescribed for postsurgical pan, but they can cause a host of unwanted side effects. Orthopaedic surgeons prescribe opioids more frequently than in any other surgical speciality. This is a rising concern to the healthcare system as it may promote the development of opioid use disorder. There is a need for alternative therapies to opioid prescribing in patients having knee surgery to reduce the extensive health risks associated with opioid medications.
Multiprofen-CC™ is a multimodal topical cream including ingredients ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%). Healthcare professionals have the option to prescribe it to patients who are encountering localized musculoskeletal pain. To date there has been no evidence-based guidance generated to evaluate the efficacy of Multiprofen-CC™ in OA patients although there is compelling evidence that its medicinal ingredients are effective in pain relief.
The aim of the proposed study is to determine if, in patients with end-stage knee OA undergoing TKA, the use of topical Multiprofen-CC™ in addition to standard of care pain management is more effective in reducing acute post-operative pain during a 6 week follow-up period. Secondary objectives include determining the effects of Multiprofen-CC™ compared to placebo on opioid use, satisfaction with pain management, and we will also identify adverse events.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 288
- Adults (18+)
- Undergoing Primary Elective TKA
- Provide informed consent
- Administration of any investigational drug in the period of 0 to 45 days before entry into the study
- Pregnancy
- Actively breastfeeding
- Unable to provide informed consent (e.g. cognitive disability)
- Unable or unwilling to follow study protocol (e.g. unwilling to apply the topical treatments as instructed)
- Have a known allergy to ketoprofen, other NSAIDs, baclofen, amitriptyline, or lidocaine, any of the study drugs or their ingredients
- Have a history of substance abuse
- Use daily opioids (other than short acting codeine) for a chronic pain condition other than knee OA
- Are undergoing a revision TKA or are scheduled for a simultaneous bilateral TKA
- Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study
- Diagnosis of uncontrolled hypertension
- Diagnosis of active peptic ulcer disease
- A history of chronic (> 3 months) anticoagulant usage
- History of impaired kidney or liver function
- Have open wounds/cuts and/or skin conditions on the knee area, other than the surgical incision
- Body Mass Index (BMI) > 50kg/m2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multiprofen-CC™ Multiprofen-CC™ plus standard treatment Standard care pain medications and topical Multiprofen-CC™ (1g TID) for 6 weeks after surgery Control Placebo plus standard treatment Standard care pain medications and visually identical topical placebo (1g TID) for 6 weeks after surgery
- Primary Outcome Measures
Name Time Method Acute postoperative pain 1, 2, 3, 4, 5, and 6 weeks postop Daily pain score on 0-10 numeric rating scale from post-op day 1 up to 6-weeks postop.
- Secondary Outcome Measures
Name Time Method Time to opioid cessation 6 weeks postop Time to opioid cessation
Safety - Adverse events up to 6 weeks postop Serious and non-serious adverse events
Cumulative opioid use measured in Morphine Equivalent Dose (MED) up to 6 weeks postop Cumulative opioid use up to 6 weeks
Satisfaction with Pain Management 6 weeks postop Satisfaction with pain management measured on a 0-10 numeric rating scale (NRS; higher score is better)
Trial Locations
- Locations (2)
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
Oakville Trafalgar Memorial Hospital
🇨🇦Oakville, Ontario, Canada